Ra Medical Surpasses 100 Patients Enrolled in Atherectomy Clinical Study

Ra Medical Systems Inc. is nearing capacity for its study of the DABRA excimer laser system. The company recently enrolled its 100th patient in the trial; the study is cleared to enroll up to 125 subjects.

Ra Medical’s study will evaluate the safety and effectiveness of the DABRA excimer laser system as an atherectomy device for treating peripheral arterial disease (PAD). 
 
“I want to recognize the support from our Ra Medical team and our physician investigators and staff for their diligence in reaching this significant enrollment milestone, particularly given the daunting challenges that arose from the COVID-19 pandemic,” said Will McGuire, Ra Medical Systems CEO. “Securing clearance for the atherectomy indication is a top priority for Ra Medical as we believe it will expand our addressable market beyond the existing clearance for crossing chronic total occlusions, or CTOs. Third-party research estimates that the combined CTO and atherectomy markets in the U.S. will approximate $900 million this year. Due to the unpredictable nature of the pandemic, we are unable to accurately predict when we will complete study enrollment. However, our goal is to reach full enrollment during the third quarter of this year and to complete six-month follow-up in early 2023.” 
 
The open-label pivotal atherectomy clinical trial can enroll subjects with symptoms of PAD (Rutherford Class 2-5) at up to 10 sites. Seven sites have been cleared for enrollment and one additional site is in the final phase of qualification. Outcome measures include safety, acute technical success and clinical success. The trial’s primary efficacy endpoint is the mean reduction in percent diameter stenosis in each patient’s primary lesion as measured by angiography immediately following treatment with DABRA and before any adjunctive treatment. The trial’s safety and clinical success endpoints are major adverse events at 30 days post-procedure and incidence of primary target lesion revascularization at six months.
 
Ra Medical Systems manufactures the DABRA excimer laser and catheters for the treatment of certain vascular diseases. DABRA has been cleared by the U.S. Food and Drug Administration for crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease and has an intended use for ablating a channel in occlusive peripheral vascular disease. In addition, DABRA has been granted CE mark clearance for the endovascular treatment of infrainguinal arteries via atherectomy and for crossing total occlusions. DABRA excimer lasers and catheters are manufactured in a 32,000-square-foot facility located in Carlsbad, Calif. The vertically integrated facility is ISO 13485 certified and is licensed by California to manufacture sterile, single-use catheters in clean room environments.